A critical review of ozanimod for the treatment of adults with moderately to severely active ulcerative colitis

Abstract

Introduction: Ozanimod is a sphingosine-1-phosphate (S1P) modulator that inhibits lymphocyte trafficking from lymph nodes to the circulation. It is approved by the U.S. Food and Drug Administration (FDA) for treatment of relapsing multiple sclerosis and most recently for the management of moderate-severe ulcerative colitis (UC). Areas covered: Here we review the status of drugs approved for moderate-severe UC, the unmet needs in the management of UC, proposed mechanisms of action of S1P modulators, clinical data regarding ozanimod in UC and emerging S1P modulators being evaluated in inflammatory bowel disease. Expert opinion: Ozanimod is superior to placebo in inducing and maintaining clinical and endoscopic remission in UC. Adverse events include transient asymptomatic bradycardia and first-degree atrioventricular blocks, transient asymptomatic hepatotoxicity, macular edema in patients with pre-existing risk factors, and increased risk of nasopharyngitis. Ozanimod is contraindicated in patients with clinically significant cardiovascular diseases, type II second- or third-degree atrioventricular blocks, and females of child-bearing age not using contraception. Ozanimod is the first S1P modulator to be approved for UC, offering a new therapeutic class option for patients. It has the advantages of being convenient with a once daily oral administration, non-immunogenic, and overall safe when used in patients without contraindications.